Palvella completes rolling FDA NDA submission for QTORIN rapamycin in microcystic lymphatic malformations
PVLA•Phase 3 trial met primary endpoint
The Phase 3 SELVA trial met the primary endpoint; 86% were rated Much Improved or Very Much Improved at Week 24.
Palvella targets a potential US launch in the first half of 2027 if the FDA clears the application.
FDA submission completed for QTORIN rapamycin
Palvella Therapeutics completed a rolling NDA submission to the FDA for QTORIN 3.9% rapamycin gel to treat microcystic lymphatic malformations.
FDA granted rolling review; a filing decision and any Priority Review designation are expected within 60 days.
